Peripheral nerve stimulation device for affecting parasympathetic and sympathetic activity to achieve therapeutic effects

Abstract

The present disclosure relates to devices and methods for stimulating peripheral nerves in a patient via electrical, optical, mechanical, or other stimulation, in order to change the balance between parasympathetic and sympathetic activity by selectively increasing or decreasing each of parasympathetic and sympathetic activity. In a particular application, the present disclosure relates to a device for transdermal stimulation of the vagus nerve (including the auricular branch) to selectively affect the sympathetic and parasympathetic nervous system to achieve the desired therapeutic effect in a human subject.

1 - 117 . (canceled) 
     
     
         118 . A method for treating depression in a human subject, comprising:
 (a) positioning at least two electrodes at the subject's skin, on or in the subject's ear; and   (b) treating the depression by transcutaneously delivering an electrical signal to an auricular branch of the subject's vagal nerve via the at least two electrodes, the electrical signal having a frequency in a frequency range from 10 kHz to 50 kHz, wherein the electrical signal does not produce paresthesia in the subject when delivered to the subject's ear.   
     
     
         119 . The method of  claim 118  wherein the frequency range is from 10 kHz to 25 kHz. 
     
     
         120 . The method of  claim 118  wherein the frequency is 20 kHz. 
     
     
         121 . The method of  claim 118  wherein the electrical signal includes pulses having a pulse width in a pulse width range of from 10 microseconds to 50 microseconds. 
     
     
         122 . The method of  claim 118  wherein directing the pulsed electrical signal includes delivering the pulsed electrical signal for up to one hour, no more than twice daily. 
     
     
         123 . The method of  claim 118 , further comprising halting the pulsed electrical signal for a period of from one day to one month. 
     
     
         124 . The method of  claim 118  wherein the pulsed electrical signal is delivered without inducing a perceptible sensation in the subject. 
     
     
         125 . The method of  claim 118 , further comprising adjusting at least one parameter of the pulsed electrical signal in response to sensed feedback from the subject. 
     
     
         126 . The method of  claim 118  wherein directing the pulsed electrical signal includes directing the pulsed electrical signal via at least one electrode positioned at a cymba concha of the subject's ear. 
     
     
         127 . The method of  claim 118 , further comprising selecting the frequency of the signal to be above the subject's auditory threshold. 
     
     
         128 . A method for addressing depression in a human subject, comprising:
 programming a signal generator to produce at least one electrical signal to treat depression, at least a portion of the at least one electrical signal having a frequency in a frequency range from about 10 kHz to about 50 kHz, wherein:
 the electrical signal does not produce paresthesia in the subject when delivered to the subject's ear; and 
 the signal generator is coupleable to two earpieces, each shaped to fit against skin of the subject's external ear, external ear canal, or both, each earpiece carrying at least two transcutaneous electrodes positioned to be in electrical communication with at least one auricular nerve of the subject. 
   
     
     
         129 . The method of  claim 128  wherein the frequency range is from 10 kHz to 25 kHz. 
     
     
         130 . The method of  claim 128  wherein the frequency is 20 kHz. 
     
     
         131 . The method of  claim 128  wherein the electrical signal includes pulses having a pulse width in a pulse width range of from 10 microseconds to 50 microseconds. 
     
     
         132 . The method of  claim 128  wherein the electrical signal has an amplitude in an amplitude range from 0.1 mA to 20 mA. 
     
     
         133 . The method of  claim 128  wherein the control unit is configured to deliver the electrical signal for up to one hour, and no more than twice daily. 
     
     
         134 . The method of  claim 128  wherein programming the signal generator includes programming the signal generator to halt the electrical signal for a period of from one day to one month. 
     
     
         135 . The method of  claim 128  wherein the electrical signal does not induce a perceptible sensation in the subject when delivered to the subject's ear. 
     
     
         136 . The method of  claim 128  wherein programming includes programming the signal generator to adjust at least one parameter of the electrical signal in response to sensed feedback from the subject. 
     
     
         137 . A system for delivering an electrical signal to a person having depression, the system comprising:
 a pulse generator having instructions to generate the electrical signal to address the person's depression, at least a portion of the electrical signal having:
 a frequency at or above the person's auditory frequency limit, wherein the frequency is in a frequency range of from about 10 kHz to about 50 kHz; 
 an amplitude in an amplitude range of from about 0.1 mA to about 20 mA; and 
 a pulse width in a pulse width range of from about 5 microseconds to about 50 microseconds; and 
   at least one earpiece having a curved body shaped to fit against the skin of the person's ear, wherein the earpiece carries at least two transcutaneous electrodes coupled to the pulse generator and positioned to be in electrical communication with an auricular nerve of the person.   
     
     
         138 . The system of  claim 137  wherein the frequency range is from 20 kHz to 50 kHz. 
     
     
         139 . The system of  claim 137  wherein the electrical signal is a non-paresthesia-generating electrical signal and/or a non-sensory-response-generating electrical signal. 
     
     
         140 . The system of  claim 137 , further comprising at least one sensor positioned to detect at least one physiological parameter of the person, and wherein the pulse generator has instructions to adjust one or more of the frequency, the amplitude, the pulse width, an ON time, an OFF time, and/or a delivery time based at least in part on the at least one physiological parameter. 
     
     
         141 . The system of  claim 140  wherein the at least one physiological parameter includes at least one of a blood oxygen saturation, a blood pressure, a heart rate, a heart rate variability, a parasympathetic tone, a sympathetic tone, a sympathetic-parasympathetic balance, a cortical regional blood flow, an forced expiratory volume (FEV), a breathing rate, an end tidal volume, a temperature, and/or an exertional level. 
     
     
         142 . The system of  claim 137 , further comprising an external controller configured to be in wireless communication with the pulse generator, wherein the external controller includes a mobile device having an application for controlling the pulse generator. 
     
     
         143 . The system of  claim 137  wherein the electrical signal includes a first electrical signal and a second electrical signal, and wherein pulse generator has instructions that, when executed, apply the first electrical signal to a first ear of the person and the second electrical signal to a second ear of the person. 
     
     
         144 . The system of  claim 143  wherein the first electrical signal differs from the second electrical signal. 
     
     
         145 . The system of  claim 143  wherein the frequency, amplitude, and pulse widths of the first and second electrical signals are the same, and wherein (1) the first and second electrical signals are applied to both ears simultaneously or (2) the first and second electrical signals are applied to both ears consecutively. 
     
     
         146 . The system of  claim 137  wherein the pulse generator has instructions that, when executed, generate the electrical signal over the course of at most two sessions per day. 
     
     
         147 . The system of  claim 146  wherein an individual session lasts for up to 10 minutes, up to 15 minutes, up to 20 minutes, up to 25 minutes, up to 35 minutes, up to 40 minutes, up to 45 minutes, up to 50 minutes, up to 55 minutes, or up to 1 hour.